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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03517423 |
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Date of registration:
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25/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study
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Scientific title:
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Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study |
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Date of first enrolment:
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October 4, 2018 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03517423 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Mark R Keezer, MDCM PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHUM |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All consecutive adult patients (i.e. aged at least 18 years) with focal epilepsy in
whom BRV was introduced (no more than 48 hours prior to their time of recruitment) at
participating medical centres, ambulatory or hospitalized, will be approached to
participate in the study.
Exclusion Criteria:
- We will exclude individuals with generalized epilepsy as well as those aged less than
18 years, in order to respect current Health Canada indications. We will exclude
individuals cognitively or physically unable to complete the study questionnaires.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: Brivaracetam
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Primary Outcome(s)
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proportion with at least a 50% change in seizure frequency
[Time Frame: 3 and 6 months]
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mean percent change in monthly seizure frequency
[Time Frame: 3 and 6 months]
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Secondary Outcome(s)
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mean change in irritability
[Time Frame: 3 and 6 months]
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mean change in depression
[Time Frame: 3 and 6 months]
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the proportion of individuals that are seizure free
[Time Frame: 3 and 6 months]
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change in distribution of seizure types
[Time Frame: 3 and 6 months]
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adverse effects
[Time Frame: 3 and 6 months]
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mean change in generalised anxiety
[Time Frame: 3 and 6 months]
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mean change in quality of life
[Time Frame: 3 and 6 months]
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Secondary ID(s)
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MP-02-2-18-6766
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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